Compliance Tech Specialist
Department Description: In addition to supporting the compliance functions for Transfusion Medicine, this position will also support the entire Pathology Department from a compliance standpoint. Other tasks will include CAP Proficiency Testing management and review, billing audits, POC evaluations, and report review.
Job Location: Boston, MA
Req ID: 32540BR
Job Summary: The Compliance Technical Specialist coordinates, monitors, and facilitates all Quality Assurance (QA) activities related to clinical or research lab. Responsible for implementing controls and reviewing results of processing patient care/testing to ensure that quality standards are met. In addition, the Compliance Technical Specialist participates in the development, writing and implementation of processes, programs and standard operating procedures.
- Determines that SOPs exist for all procedures in the lab and ensures that all up-to-date procedures for process control of SOPs are available to all laboratory sections. Reviews and provides written approval of all standard operating procedures written for use in the Blood Bank. Maintains master list of critical SOPs and coordinate their annual review.
- Ensures in the lab that validation principles applicable to the section or department's systems and processes exist and that adequate validation procedures have been performed. Review and provide written approval of all validation documentation.
- Participates in the development, implementation, and administration Equipment Process Control procedures. Approves in writing all equipment documentation.
- Error/Accident Reports, Complaints, and Adverse Reactions. Develops and implements procedures for the Occurrence Reporting Program. Participates in the administration of the principles of the Error Management Program; review quality procedures to ensure that all complaints are properly investigated.
- Ensures that procedures are in place for thorough investigation and complete documentation of donor and recipient adverse reactions. Ensures that biological product deviations are reported to the FDA. Monitors the Lab Quality Mailbox.
- Bachelor's degree in Life Sciences or Medical Technology required.
- 3-5 years related work experience required.
- Strong knowledge of laboratory accreditation requirements.
- Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.
- Certifications in at least one of the following areas: ASCP, CIH, CSP or HEM.
- Experience in Transfusion Medicine.
- Strong organizational skills and the ability to integrate and synthesize new information quickly; including compilation of data into reports.
- Decision Making: Ability to make decisions that are guided by precedents, policies and objectives. Regularly makes decisions and recommendations on issues affecting a department or functional area.
- Problem Solving: Ability to address problems that are highly varied, complex and often non-recurring, requiring staff input, innovative, creative, and Lean diagnostic techniques to resolve issues.
- Independence of Action: Ability to set goals and determines how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction.
- Written Communications: Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.
- Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
- Knowledge: Ability to demonstrate in-depth knowledge of concepts, practices and policies with the ability to use them in complex varied situations.
- Team Work: Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment and improving workflows. Results may impact the operations of one or more departments.
- Customer Service: Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner.
Physical Nature of the Job:
Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally